Visit the WIS FDA Info.com for the best regulatory news and information

Many of our recently held briefings are available on audiocassette files. Visit our Tapes Library for our highly regarded series on:

  21 CFR Part 11
  Adverse Event
Reporting
  Branded/Generic
Drug Policy
  Clinical Research
  Computer Validation 
  FDA Enforcement
  Human Research Protections
  Prescription Drug Marketing
  Order Form

 

 


Tapes Library
Computer Validation: Using Commercial Off the Shelf (COTS) SOPs in Existing IT Systems
Speaker:
T. Quinn, D. Weitz
Date of Briefing:
March 25, 2003
Approximate length:
90 minutes
Description:
Our presenters explain how to substantially lower the cost of qualifying infrastructures to comply with multiple regulatory standards and diligent business practices. Click here for more details:
Using Commercial Off the Shelf (COTS) SOPs in Existing IT Systems
Price:
$275 Tape
ttttttttttttt
Go to the Order Form

Tapes Library

Computer Validation: Auditing Clinical Data Management Systems
Speaker:
Len Grunbaum, president, META Solutions
Date of Briefing:
Jan. 30, 2002
Approximate length:
One hour
Description:
Get practical recommendations on how to audit existing clinical data management systems for Part 11 compliance, and what to look for in new systems.  Find out who should be on the auditing team and their roles, and the steps to follow for a systematic, thorough and effective audit.
Price:
$325 Tape
ptovvvvv
Go to the Order Form



Tapes Library
Computer Validation: Validating Commercial Off-the-Shelf Applications
Speaker:
Michael Symons, compliance specialist, PENSA Technology Solutions
Date of Briefing:
Jan. 23, 2002
Approximate length:
One hour
Description:

Failure to adequately validate large-scale manufacturing computer systems not only can affect operations, but can delay new product approvals.  Find out proven approaches for evaluating the Part 11 compliance of your drug manufacturing systems.

Price:
$325 Tape
rrrrrrrrrrr
Go to the Order Form
Tapes Library
Computer Validation: Validating Commercial Off-the-Shelf Applications
Speaker:
Derek Wimmer, president, Wimmer Systems
Date of Briefing:
Jan. 16, 2002
Approximate length:
One hour
Description:

Find out when off-the-shelf programs, such as Excel and Word, must be validated, and get proven validation techniques when source code is unavailable and vendor audits are not an option.

Price:
$325 Tape
rrrrrrrrrrr
Go to the Order Form
 

 

Page last updated October 16, 2006

Washington Information Source © Copyright 2006

208 South King Street, Suite 303, Leesburg, VA 20175
Tel: (703) 779-8777 . Fax: (703) 779-2508
service@fdainfo.com
. www.expertbriefings.com

This site has been accessed: times since April 7, 2003